12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia - Full Text View

Sponsor:	LifeCycle Pharma A/S
Information provided by:	LifeCycle Pharma A/S
ClinicalTrials.gov Identifier:	NCT00664859

Purpose

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Condition	Intervention	Phase
Dyslipidemia	Drug: LCP-AtorFen	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Procetofen Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by LifeCycle Pharma A/S:

Primary Outcome Measures:

The primary endpoints are the mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind baseline (Week 0) to end-of-treatment (Week 52), and from the open-label baseline (Visit 1) to Week 52 (Visit 8). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number (percentage) of subjects at end-of-treatment (Visit 8; Week 52) who achieve the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) goal of non-HDL cholesterol of 30 mg/dL higher than the LDL cholesterol. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	220
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental Open-label LCP-AtorFen	Drug: LCP-AtorFen All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.

Detailed Description:

POPULATION:

Subjects with mixed dyslipidemia (non-HDL cholesterol > 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.

STUDY DESIGN AND DURATION:

This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).

Exclusion Criteria:

Study drug compliance <70% in the double-blind study.
Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.
Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic.
Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.
Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.
Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.
Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.
Other exclusion conditions might apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664859

Locations

United States, Illinois
Radiant Research, 515 N State St, Suite 2700
Chicago, Illinois, United States, 60610

Sponsors and Collaborators

LifeCycle Pharma A/S

Investigators

Principal Investigator:	Jeff Geohas, MD	Radiant Research
Study Director:	Dennis McCluskey, MD	Radiant Resaerch
Study Director:	Harry Geisberg, MD	Radiant Research
Study Director:	Chivers Woodruff, Jr, MD	Radiant Research
Study Director:	Michael Noss, MD	Radiant Research
Study Director:	Michele Reynolds, MD	Radiant Research
Study Director:	James Zavoral, MD	Radiant Research
Study Director:	Randall Severance, MD	Radiant Research
Study Director:	Stephen Halpern, MD	Radiant Research
Study Director:	Linda Murray, MD	Radiant Research
Study Director:	Eduardo Cuevas, MD	Radiant Research
Study Director:	Cynthia Strout, MD	Coastal Carolina Research
Study Director:	Mark Kipnes, MD	Diabetes and Glandular Research Center, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	LifeCycle Pharma A/S ( LifeCycle Pharma A/S )
Study ID Numbers:	LCP-AtorFen-2001-1X
Study First Received:	April 21, 2008
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00664859 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by LifeCycle Pharma A/S:

LCP-AtorFen
Non-HDL cholesterol
Triglycerides
HDL cholesterol

LDL cholesterol
Atorvastatin
Fenofibrate

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Procetofen
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010